BLINCYTO™

Generic Name: blinatumomab
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20120216Adult subjects with Relapsed/Refractory (R/R) Philadelphia Chromosome Positive (Ph+) B-precursor Acute Lymphoblastic Leukemia (ALL)2A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE; Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)
MT103-104CANCER - LIQUID TUMORS1

An Open-Label, Multi-Center Phase 1 Study to Investigate the Tolerability and Safety of a Continuous Infusion of the Bispecific T-Cell Engager MT103 in Subjects With Relapsed Non-Hodgkin’s Lymphoma (NHL)

MT103-202CANCER - LIQUID TUMORS2

An Open-label, Multicenter Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of the Bi-specific T-cell Engager (BiTE®) MT103 in Patients with Minimal Residual Disease (MRD) of Positive B-precursor Acute Lymphoblastic Leukemia (ALL)

MT103-203CANCER - LIQUID TUMORS2

A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BITE® Antibody Blinatumomab in Adult Subjects with Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia

MT103-205Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)1/2A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE„µ Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
MT103-206CANCER - LIQUID TUMORS2

An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

MT103-208CANCER - LIQUID TUMORS2

An Open Label, Multicenter, Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of the Bispecific T-Cell Engager (BiTE®) Blinatumomab in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

MT103-211CANCER - LIQUID TUMORS2

An Open-label, Multicenter, Phase 2 Study to Evaluate Efficacy and Safety of the Bi-specific T cell Engager (BiTE®) Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

MT103-311Adult Subjects with Relapsed/Refractory (R/R) B-precursor ALL3A Phase 3, Randomized, Open-label Study Investigating the Efficacy of the BiTE; Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)